(Yicai) Jan. 27 -- China has suspended the import, sale, and use of an Alzheimer's treatment and an active pharmaceutical ingredient used in cold medicines made in India due to their procurers' inadequate product quality control capabilities.

Imports of Sun Pharmaceutical Industries' rivastigmine tartrate capsules, used to treat mild to moderate Alzheimer's disease, and Supriya Lifescience's chlorpheniramine maleate API, which is common in compound cold medicines, have been banned, the National Medical Products Administration announced late yesterday.

Sun Pharma's quality management department had inadequate performance in the production of rivastigmine, conducted insufficient risk assessment of some batches containing marketed products with excessive impurities, and failed to take timely and effective measures, the NMPA said. In addition, its contamination prevention measures during production did not comply with China's relevant regulations on pharmaceutical production quality management.

Regarding Supriya Lifescience, it failed to ensure that the production and inspection of each batch of released chlorpheniramine maleate API complied with relevant regulations and registration requirements during production, the NMPA noted. Its production facility also did not implement effective measures to prevent the entry of insects and other animals, failing to meet China's drug production quality management and drug approval regulations.

Supriya Lifescience is one of the world's top five manufacturers of chlorpheniramine maleate API, according to the findings of a survey by Hengce Research. The suspension of such imports will likely impact the production and sales of Chinese cold medicine makers.

In accordance with the NMPA's requirements, Supriya Lifescience's chlorpheniramine maleate API cannot be used for the production of pharmaceutical preparations in China, and products made by Chinese drugmakers using the ingredient will not be released. For medicinal formulations already on the market, the marketing authorization holders need to immediately conduct investigations and evaluations and take necessary risk control measures based on the assessment results.

This is the second time China has banned imports of Supriya Lifescience's chlorpheniramine maleate API. In March 2020, the NMPA took such action due to some production processes not being handled in accordance with Good Manufacturing Practices requirements.

Editors: Tang Shihua, Martin Kadiev